Dima Italia Srl
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Dima Italia Srl makes
Dima Italia Srl manufactures ventilator devices, including the PEGASO V and NEGAVENT Respirator (Model DA-3 Plus), as well as the NEGAVENT Plus PEGASO Cough (Model DA-3 Plus). These products are designed for respiratory support and cough assistance in clinical settings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States.
Catalogue
Pegaso V, Negavent Respirator, Model: Da-3 Plus Ref K072290
510(k) 510(k)Negavent Plus Pegaso Cough, Model: Da-3 Plus Ref K072292
CE MDD 510(k) 510(k)
FDA establishments
- Dima Italia SRL Bologna · IT FEI 3007123976
Frequently asked questions
How many devices does Dima Italia Srl have in the registry?
The registry currently lists 2 devices for Dima Italia Srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dima Italia Srl's devices?
Among its 2 most recently registered devices, Dima Italia Srl has devices listed in FDA 510(k) (2 devices).
What risk classes do Dima Italia Srl's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dima Italia Srl's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dima Italia Srl in the registry?
The most recently registered devices listed for Dima Italia Srl include PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS and NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS.
Which FDA establishments are linked to Dima Italia Srl?
1 FDA establishment is linked to Dima Italia Srl in the registry; they are listed on the company page.